Roundup: COVID Linked to Higher Pregnancy Risks; Pfizer-BioNTech Postpone Kids' Vaccine Approval Request; and More

NIH Study: Moderate-to-Severe COVID-19 Linked to Higher Risk of Pregnancy Complications

Pregnant women with moderate to severe COVID-19 carry a greater risk of pregnancy complications, in addition to their own risks from to the virus, compared to pregnant women without COVID-19, according to a new study funded by the U.S. National Institutes of Health (NIH).

The study, published in the Journal of the American Medical Association, focused on nearly 2,400 pregnant women infected with COVID-19. Researchers found that these women were at a higher risk of having a cesarean delivery, delivering a preterm baby, or falling seriously ill from hypertensive (high blood pressure) disorders of pregnancy, postpartum hemorrhage, or from a non-COVID infection.

“They were also more likely to lose the pregnancy or to have an infant die during the newborn period. Mild or asymptomatic infection was not associated with increased pregnancy risks,” the NIH states.

However, mild or asymptomatic COVID infections were not linked to higher pregnancy risks.

“The findings underscore the need for women of child-bearing age and pregnant individuals to be vaccinated and to take other precautions against becoming infected with COVID-19,” said Diana Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funded the study. “This is the best way to protect pregnant women and their babies.”

The study was conducted by Torri D. Metz, M.D., of the University of Utah, Salt Lake City, and colleagues in the NICHD Maternal-Fetal Medicine Units Network.

The study covered more than 13,000 pregnant women from 17 U.S. hospitals, with about 2,400 of them infected with COVID. Participants delivered their babies between March 1 and December 31, 2020, before COVID vaccinations was available.

“Pregnant individuals with COVID-19 are at increased risk of intensive care unit (ICU) admission, mechanical ventilation, and death compared with both pregnant individuals without COVID-19 infection and nonpregnant adults with COVID-19 infection,” the study states.

Pfizer-BioNTech Postpone FDA Request for Vaccine for Kids Under 5

The U.S. Food and Drug Administration (FDA) has postponed a meeting of its advisory board that had been scheduled for Feb. 15 to review Pfizer-BioNTech’s application to authorize a COVID-19 vaccine for children, 6 months through 4 years of age.

The postponement came after Pfizer-BioNTech notified the FDA of “additional findings from its ongoing clinical trial,” the FDA said Friday. The postponement means that vaccines for this age group will not be available in the coming weeks, as previously thought.

“This will give the agency (FDA) time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines,” the FDA said.

Pfizer-BioNTech said in a news release Friday that it will wait for its data on a three-dose series of the vaccine for this age group, because three doses “may provide a higher level of protection.” Data on the third dose is expected in early April, the company said.

“This is also supported by recent observations of three-dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real-world vaccine protection for omicron, compared to the two-dose regimen,” the companies said.

Study: COVID-19 mRNA Vaccines Deemed as Safe for Cancer Patients as for Those With No History of Cancer

The COVID-19 mRNA vaccines from Pfizer-BioNTech and Moderna are as safe for cancer patients as they are for everyone else, according to an observational study by Fox Chase Cancer Center in Philadelphia published in the Journal of the National Comprehensive Cancer Network.

Researchers say this is the largest published study “examining the short-term adverse events of COVID-19 vaccination in patients with cancer and the potential impact of active cancer treatment on such effects.”

Post-vaccination symptoms were common and reported with similar frequencies by both patients with and those with no history of cancer. Over 1,700 participants were involved in the study, more than two-thirds of whom had a history of cancer. Local pain at the injection site was the most frequently reported symptom and did not differ in frequency between patients with and without cancer after the first or second dose of either vaccine.

For patients with cancer, adverse events that were reported more frequently after the second dose included fatigue, joint pain, fever, chills, headache, and nausea. Allergic reactions were rare after both doses.

Researchers noted that earlier studies have confirmed some vaccine hesitancy among patients with cancer. “Media reports are an undoubted influence, especially when misleading or misinformed,” the study’s authors said.

The study’s conclusion: “The most effective remedy for this distrust is education. Widespread dissemination of results such as those reported in this study will ensure that a safe and effective COVID-19 vaccine—justly celebrated as a scientific and medical triumph—is provided to the patients, including those with cancer, who stand to benefit from it most.”

CDC: New ‘Real-World’ Data Reinforces Protection Masks Offer in Indoor Public Settings

Wearing any type of mask indoors is associated with significant protection from COVID-19, compared to going maskless — but the higher-quality N95 and KN95 masks provide the protection, says a new report from the U.S. Centers for Disease Control and Prevention (CDC).

In indoor public settings, surgical masks reduce the chances of testing positive by 66 percent, the CDC projects. The N95 and KN95 masks further decrease the risk of infection, offering an 83 percent protection, the agency said.

“Wearing a cloth mask was associated with lower adjusted odds of a positive test, compared with never wearing a face covering — but was not statistically significant,” the CDC added.

The research was conducted by the California Department of Public Health between Feb. 18 and Dec. 1, 2021 — before the omicron variant became dominant in the U.S. Researchers surveyed 652 people who had recently tested positive for COVID-19, and matched them with 1,176 who had tested negative. All participants were asked whether they had been in stores, churches, schools, restaurants and other indoor public settings in the 14 days before their test. And they were asked if they wore a mask, and how often.

The researchers conceded that relying on a survey participant’s memory may limit the reliability of the results, but researchers said they took steps to “minimize recall bias.”

“These data from real-world settings reinforce the importance of consistently wearing face masks or respirators (N95 and KN95 masks) to reduce the risk of acquisition of COVID-19 infection among the general public in indoor community settings,” the CDC concluded.